This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Modifications to in-process acceptance criteria and final in-process acceptance criteria
Device | ORSIRO Sirolimus Eluting Coronary Stent System |
Generic Name | Coronary Drug-eluting Stent |
Applicant | Biotronik, Inc |
Date Received | 2021-01-19 |
Decision Date | 2021-02-17 |
PMA | P170030 |
Supplement | S014 |
Product Code | NIQ |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | Yes |
Applicant Address | Biotronik, Inc 6024 Jean Road lake Oswego, OR 97035 |
Supplement Number | Date | Supplement Type |
---|---|---|
P170030 | Original Filing | |
S014 | 2021-01-19 | 30-day Notice |
S013 | 2020-10-16 | 30-day Notice |
S012 | 2020-10-16 | 30-day Notice |
S011 | 2020-10-02 | Normal 180 Day Track No User Fee |
S010 | 2020-09-21 | 30-day Notice |
S009 | ||
S008 | 2020-07-22 | 30-day Notice |
S007 | ||
S006 | 2020-06-02 | 30-day Notice |
S005 | 2019-11-04 | 30-day Notice |
S004 | 2019-09-27 | 30-day Notice |
S003 | 2019-04-17 | Normal 180 Day Track No User Fee |
S002 | ||
S001 |